CN116077126A - Vascular occlusion device, manufacturing method and installation method thereof - Google Patents

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a vascular occlusion device, a manufacturing method and an installation method thereof. The manufacturing method of the vascular occlusion device comprises the following steps: an outer layer braiding structure with a hollow inner cavity is adopted, and an undispersed plugging structure penetrates into the hollow inner cavity of the outer layer braiding structure along the axial direction of the outer layer braiding structure; the plugging structure comprises a plurality of nonmetal flexible strips with long strips, and each flexible strip extends along the axial direction of the outer layer braiding structure; fixing the first end of the outer braided structure and the first end of the plugging structure by using a fixing sleeve; the blocking structure is subjected to divergent treatment, so that the middle part of the blocking structure is mutually wound and divergently filled in the whole inner cavity of the outer layer woven structure; and fixing the second end of the outer layer woven structure and the second end of the plugging structure by using another fixing sleeve. According to the invention, the plugging structure comprises a plurality of nonmetallic flexible strips, so that the embolism efficiency can be remarkably improved on the basis of reducing the metal consumption.

Description

Translated fromChinese

血管封堵器及其制作方法和安装方法Vascular occluder and its manufacturing method and installation method

技术领域technical field

本发明属于医疗器械技术领域，具体涉及一种血管封堵器及其制作方法和安装方法。The invention belongs to the technical field of medical devices, and in particular relates to a blood vessel occluder and a manufacturing method and an installation method thereof.

背景技术Background technique

经导管血管栓塞术(transcatheter arterial embolization)，是介入放射学的最重要基本技术之一。为在X线透视下经导管向靶血管内注入或送入栓塞物质，使血管闭塞从而达到预期治疗目的的技术。该技术具有微创性、全程影像引导和靶血管选择性，使得栓塞的准确性和可控性大大增强，成为革命性的临床治疗方法。Transcatheter arterial embolization is one of the most important basic techniques in interventional radiology. It is a technique for injecting or sending embolic substances into the target blood vessel through the catheter under X-ray fluoroscopy to occlude the blood vessel so as to achieve the intended therapeutic purpose. This technology is minimally invasive, fully image-guided, and target-vessel-selective, greatly enhancing the accuracy and controllability of embolization, and has become a revolutionary clinical treatment method.

栓塞物质经导管注入到血管内，随之血管被栓塞，进而会对靶血管、靶器官和局部学流动力学造成不同程度的影响。The embolic material is injected into the blood vessel through the catheter, and then the blood vessel is embolized, which will affect the target blood vessel, target organ and local flow dynamics to varying degrees.

现有技术中的血管封堵器一般会采用金属弹簧圈类，通常此类栓塞物质能通过细小的导管内径进入人体血管，出导管后在血管内膨胀或盘曲成形，大多用于栓塞较导管直径大得多的血管或血管瘤腔(3～15mm)。如血管封堵器类公开号为TW362007B公开的一种可植入之血管闭塞裝置，其公开了一种由超弹性、自膨胀的记忆合金丝多金属网设计编织而成的血管闭塞裝置，其通过多层金属网设计，增加金属丝密度和加大对血流的干扰；同时尺寸规格较多可以适应不同的血管。但这种血管闭塞装置金属含量很大，长期放置于人体内，会造成人体金属中毒。另外由于金属丝之间的网格间隙较大，止血性不足。The vascular occluders in the prior art generally use metal spring coils. Usually, such embolic substances can enter human blood vessels through the small inner diameter of the catheter, and expand or twist in the blood vessel after exiting the catheter. Most of them are used for embolization. Much larger blood vessels or hemangioma cavity (3 ~ 15mm). For example, an implantable vascular occlusion device disclosed in the publication number TW362007B of vascular occluders discloses a vascular occlusion device designed and woven from superelastic and self-expanding memory alloy wire multi-metal mesh. Through the design of multi-layer metal mesh, the density of metal wires is increased and the interference to blood flow is increased; at the same time, there are many sizes and specifications to adapt to different blood vessels. However, this vaso-occlusive device has a large metal content, and if it is placed in the human body for a long time, it will cause metal poisoning in the human body. In addition, due to the large mesh gap between the wires, the hemostasis is insufficient.

为此，有必要对其进行新的设计，以克服上述不足。For this reason, it is necessary to carry out new design to it, to overcome above-mentioned deficiency.

发明内容Contents of the invention

本发明针对现有技术中的血管封堵器的金属丝之间的网格间隙较大，止血性不足，且金属含量过大导致人体金属中毒的技术问题，目的在于提供一种血管封堵器及其制作方法和安装方法。The present invention aims at providing a blood vessel occluder for the technical problems that the grid gap between the metal wires of the vascular occluder in the prior art is relatively large, the hemostatic performance is insufficient, and the metal content is too large to cause metal poisoning in the human body. and a manufacturing method and an installation method thereof.

血管封堵器的制作方法包括如下步骤：The manufacture method of blood vessel occluder comprises the steps:

S1，采用具有中空内腔的外层编织结构，将未发散的封堵结构沿所述外层编织结构的轴线方向穿于所述外层编织结构的所述中空内腔内；S1, using an outer braided structure with a hollow inner cavity, and passing a non-divergent blocking structure into the hollow inner cavity of the outer braided structure along the axial direction of the outer braided structure;

所述封堵结构包括若干具有长条形的非金属柔性长条，各所述柔性长条均沿所述外层编织结构的轴线方向延伸；The sealing structure includes several long non-metallic flexible strips, and each of the flexible strips extends along the axial direction of the outer braided structure;

S2，利用一个固定套对所述外层编织结构的第一端和所述封堵结构的第一端进行固定；S2, using a fixing sleeve to fix the first end of the outer braided structure and the first end of the sealing structure;

S3，对所述封堵结构进行发散处理，使所述封堵结构中间部分相互缠绕且发散地充盈于所述外层编织结构的整个内腔内；S3, performing divergent processing on the blocking structure, so that the middle parts of the blocking structure are intertwined and filled in the entire lumen of the outer braided structure in a divergent manner;

S4，利用另一个固定套对所述外层编织结构的第二端和所述封堵结构的第二端进行固定。S4, using another fixing sleeve to fix the second end of the outer braided structure and the second end of the blocking structure.

在一实施例中，所述外层编织结构采用记忆金属丝编织而成，所述外层编织结构采用记忆金属编织成型，并在编织完成后采用热定型的方式在所述外层编织结构内形成所述中空内腔，所述中空内腔的内径大于所述外层编织结构的所述第一端和所述第二端的内径；In one embodiment, the outer braided structure is braided with memory metal wires, the outer braided structure is braided with memory metal, and heat-set in the outer braided structure after braiding is completed. forming the hollow lumen having an inner diameter greater than the inner diameters of the first end and the second end of the outer braided structure;

步骤S3中，在对所述封堵结构进行发散处理时，来回拉扯所述外层编织结构的第二端，使得所述封堵结构相互缠绕且发散地填充于所述外层编织结构的整个内腔内。In step S3, when the sealing structure is divergently processed, the second end of the outer braided structure is pulled back and forth, so that the sealing structures are intertwined and filled in the entire outer braided structure in a divergent manner Inside the lumen.

在一实施例中，在对所述封堵结构进行发散处理时，来回拉扯所述外层编织结构的第二端，使得所述封堵结构相互缠绕且发散地填充于所述外层编织结构的整个内腔内的具体步骤如下：In one embodiment, when performing divergent treatment on the blocking structure, the second end of the outer braided structure is pulled back and forth, so that the blocking structures are intertwined and filled in the outer braided structure in a divergent manner The specific steps within the entire lumen are as follows:

步骤V1：带动所述外层编织结构的远端往远离所述外层编织结构的近端方向运动，所述外层编织结构包覆住更多的各所述柔性长条，松开所述外层编织结构的远端，所述外层编织结构的远端回弹，则各所述柔性长条就被发散地收入所述外层编织结构内；Step V1: Drive the distal end of the outer braided structure to move away from the proximal end of the outer braided structure, the outer braided structure covers more of the flexible strips, and loosen the The distal end of the outer braided structure, the distal end of the outer braided structure rebounds, and each of the flexible strips is divergently received into the outer braided structure;

重复上述V1步骤多次，直至各所述柔性长条相互缠绕且发散地填充于所述外层编织结构的整个内腔内；Repeat the above step V1 for several times until each of the flexible strips is intertwined with each other and divergently fills the entire inner cavity of the outer braided structure;

和\或，步骤S3中，在对所述封堵结构进行发散处理时，用工具对柔性长条进行拨散。And/or, in step S3, when the sealing structure is divergently processed, the flexible long strips are loosened with a tool.

在一实施例中，步骤S1中，所述外层编织结构的近端具有预设长度的近端收束段，所述外层编织结构的远端具有预设长度的远端收束段，所述封堵结构穿过外层编织结构的中间通道后，至少预设长度的所述封堵结构位于所述近端收束段内，优选所述封堵结构与所述近端收束段的近端具有预设距离；In one embodiment, in step S1, the proximal end of the outer braided structure has a proximal constricting segment of a preset length, and the distal end of the outer braided structure has a distal converging segment of a preset length, After the blocking structure passes through the middle channel of the outer braided structure, at least a preset length of the blocking structure is located in the proximal constricting segment, preferably the blocking structure and the proximal converging segment The proximal end of has a preset distance;

步骤S2中，利用所述固定套进行固定之前，在所述近端收束段内重叠的所述外层编织结构和所述封堵结构采用近端收束件进行捆扎收束，捆扎收束至所述近端收束段的近端端部，所述固定套套设于所述近端收束件外，并将所述固定套近端侧的所述外层编织结构和所述封堵结构全部去除；In step S2, before fixing with the fixing sleeve, the outer braided structure and the blocking structure overlapped in the proximal constricting section are bundled and constricted using a proximal constricting member, and the constricting To the proximal end of the proximal converging section, the fixing sleeve is sleeved outside the proximal constricting member, and the outer braided structure on the proximal side of the fixing sleeve and the sealing All structures are removed;

和\或，步骤S1中，通过对一根柔性长条在所述中间通道对折或来回折叠的方式实现所述封堵结构穿过外层编织结构的中间通道；And/or, in step S1, realize that the blocking structure passes through the middle passage of the outer braided structure by folding a flexible strip in half or back and forth in the middle passage;

和\或，步骤S2中，在利用所述固定套进行固定之后，还将所述固定套置入近端钢套内进行压合固定；And/or, in step S2, after using the fixing sleeve for fixing, the fixing sleeve is also inserted into the proximal steel sleeve for press-fitting and fixing;

和\或，步骤S3中，在对所述封堵结构进行发散处理后，保证至少预设长度的所述封堵结构位于所述远端收束段内，优选所述封堵结构与所述远端收束段的远端具有预设距离；And/or, in step S3, after performing divergent processing on the blocking structure, it is ensured that at least a preset length of the blocking structure is located in the distal converging section, preferably the blocking structure is in contact with the The distal end of the distal constriction section has a preset distance;

步骤S4中，利用所述固定套进行固定之前，在所述远端收束段内重叠的所述外层编织结构和所述封堵结构采用远端收束件进行捆扎收束，捆扎收束至所述远端收束段的远端端部，所述固定套套设于所述远端收束件外，并将所述固定套远端侧的所述外层编织结构和所述封堵结构全部去除；In step S4, before fixing with the fixing sleeve, the outer braided structure and the blocking structure overlapped in the distal constricting section are bundled and constricted using a distal constricting member, and the constricting To the distal end of the distal converging section, the fixing sleeve is sleeved outside the distal constricting member, and the outer braided structure on the distal side of the fixing sleeve and the sealing All structures are removed;

和\或，步骤S4中，在利用所述固定套进行固定之后，还将所述固定套置入远端钢套内进行压合固定。And/or, in step S4, after using the fixing sleeve for fixing, the fixing sleeve is also put into the distal steel sleeve for press-fitting and fixing.

本发明还提供了一种血管封堵器，包括：The present invention also provides a blood vessel occluder, comprising:

一外层编织结构，具有中空内腔；An outer braided structure with a hollow inner cavity;

一封堵结构，若干具有长条形的柔性长条，各所述柔性长条均沿所述外层编织结构的长度方向延伸，各所述柔性长条中间部分相互缠绕且发散地充盈于所述内腔中；Blocking structure, several long flexible strips, each of the flexible strips extends along the length direction of the outer braided structure, and the middle parts of each of the flexible strips are intertwined and filled in the divergent way in the cavity;

两个固定套，一个所述固定套固定于所述外层编织结构的第一端和所述封堵结构的第一端外，另一个所述固定套固定于所述外层编织结构的第二端和所述封堵结构的第二端外。Two fixing sleeves, one fixing sleeve is fixed on the first end of the outer braided structure and the first end of the sealing structure, and the other fixing sleeve is fixed on the first end of the outer braided structure two ends and the second end of the plugging structure.

在本实施例中，将封堵结构发散于所述外层编织结构过程中，可先将未发散的封堵结构沿所述外层编织结构的轴线方向穿于所述外层编织结构的所述中空内腔内；In this embodiment, during the process of diverging the sealing structure into the outer braided structure, the undiverged sealing structure may first be passed through the outer braided structure along the axial direction of the outer layer braided structure. Inside the hollow cavity;

来回拉扯所述外层编织结构的第二端，使得所述封堵结构相互缠绕且发散地填充于所述外层编织结构的整个内腔内。The second end of the outer braided structure is pulled back and forth, so that the blocking structures are intertwined and filled in the entire lumen of the outer braided structure in a divergent manner.

在本实施例中，所述外层编织结构采用镍钛丝编织成型，并通过热定性形成所述中空内腔，所述中空内腔的内径大于所述外层编织结构的第一端和第二端的内径；In this embodiment, the outer braided structure is formed by braiding nickel-titanium wire, and the hollow inner cavity is formed by heat setting, and the inner diameter of the hollow inner cavity is larger than the first end and the second end of the outer braided structure. inner diameter of both ends;

所述血管封堵器包括N个所述外层编织结构，第i节的所述外层编织结构的第一端与所述第i+1节的所述外层编织结构的第二端连接，所述N为大于等于2的自然数，所述i为大于等于1的自然数。The blood vessel occluder includes N outer braided structures, the first end of the outer braided structure of the i-th section is connected to the second end of the outer braided structure of the i+1th section , the N is a natural number greater than or equal to 2, and the i is a natural number greater than or equal to 1.

在本实施例中，所述外层编织结构的第一端和第二端夹持各所述柔性长条。In this embodiment, the first end and the second end of the outer braided structure clamp each of the flexible strips.

在本实施例中，所述外层编织结构的近端和所述封堵结构的近端重叠处采用近端收束件收束，一个所述固定套套设于所述近端收束件外；In this embodiment, the overlap between the proximal end of the outer braided structure and the proximal end of the closure structure is converged by a proximal constricting member, and one of the fixing sleeves is sleeved outside the proximal constricting member ;

所述外层编织结构的远端和所述封堵结构的远端重叠处采用远端收束件收束，另一个所述固定套套设于所述远端收束件外；The distal end of the outer braided structure overlaps with the distal end of the blocking structure with a distal constricting member, and the other fixing sleeve is sleeved outside the distal constricting member;

和\或，所述血管封堵器还包括：And\Or, described blood vessel occluder also comprises:

一近端钢套，近端设置有内螺纹，所述近端钢套压合于近端的所述固定套外；A proximal steel sleeve, the proximal end is provided with an internal thread, and the proximal steel sleeve is pressed on the outside of the fixed sleeve at the proximal end;

一远端钢套，压合于远端的所述固定套外；A distal steel sleeve, press-fitted outside the fixed sleeve at the distal end;

和\或，所述外层编织结构采用金属丝编织定型而成，所述金属丝采用镍钛合金、钴铬合金和铂铱合金中的一种或多种，所述金属丝的直径为0.02mm～0.15mm；And/or, the outer braided structure is braided and shaped by metal wire, and the metal wire is one or more of nickel-titanium alloy, cobalt-chromium alloy and platinum-iridium alloy, and the diameter of the metal wire is 0.02 mm～0.15mm;

和\或，所述柔性长条聚四氟乙烯、超高分子聚乙烯和其他高分子聚合物材料中的一种或多种，所述柔性长条的直径为0.05mm～0.15mm，所述柔性长条的根数为10～24根；And/or, one or more of the flexible strips of polytetrafluoroethylene, ultra-high molecular polyethylene and other polymer materials, the diameter of the flexible strips is 0.05mm to 0.15mm, the The number of flexible strips is 10 to 24;

和\或，所述固定套、所述近端钢套和所述远端钢套均采用镍钛合金、铂铱合金和高分子材料中的一种或者多种组成，所述固定套、所述近端钢套和所述远端钢套的外径均为0.9mm～1.4mm；And/or, the fixed sleeve, the proximal steel sleeve and the distal steel sleeve are all made of one or more of nickel-titanium alloy, platinum-iridium alloy and polymer materials, and the fixed sleeve, the The outer diameters of the proximal steel sleeve and the distal steel sleeve are both 0.9 mm to 1.4 mm;

和\或，所述外层编织结构为中空圆柱形盘或中空圆锥形盘；And/or, the outer braided structure is a hollow cylindrical disc or a hollow conical disc;

和\或，所述血管封堵器包括一个或多个所述外层编织结构，位于远端的所述外层编织结构的远端端面为弧形面；And/or, the blood vessel occluder includes one or more outer braided structures, and the distal end surface of the outer braided structure at the distal end is an arcuate surface;

当所述血管封堵器包括至少两个所述外层编织结构时，位于近端的所述外层编织结构为中空圆柱形盘。When the blood vessel occluder includes at least two outer braided structures, the outer braided structure located at the proximal end is a hollow cylindrical disc.

本发明还提供了一种上述的血管封堵器的安装方法，其特征在于，所述血管封堵器的外层编织结构的远端端面为弧形面，对所述血管封堵器的安装方法包括：The present invention also provides a method for installing the above-mentioned blood vessel occluder, which is characterized in that the distal end surface of the outer braided structure of the blood vessel occluder is an arc-shaped surface, and the installation of the blood vessel occluder Methods include:

将血管封堵器压缩并通过输送装置输送至目标位置后，所述血管封堵器从所述输送装置的导管鞘中被释放到人体内血管中时，所述血管封堵器的远端侧首先被释放；After the blood vessel occluder is compressed and delivered to the target position through the delivery device, when the blood vessel occluder is released from the catheter sheath of the delivery device into the blood vessel in the human body, the distal side of the blood vessel occluder first to be released;

当所述血管封堵器的远端侧在释放后，对所述血管封堵器的大小进行诊断，当所述血管封堵器的远端侧与所述血管封堵器在人体外未被压缩前具有相同的外轮廓，则认为所述血管封堵器较血管偏小，当所述血管封堵器的远端侧被压缩成长条状或偏长条状时，则认为所述血管封堵器较血管偏大；When the distal side of the blood vessel occluder is released, the size of the blood vessel occluder is diagnosed, when the distal side of the blood vessel occluder is not If it has the same outer contour before compression, it is considered that the vascular occluder is smaller than the blood vessel; The occluder is larger than the blood vessel;

将偏小或偏大的所述血管封堵器通过输送装置回收，换一个型号的血管封堵器继续至目标位置释放并诊断，直至未出现偏小或偏大现象时，认为当前所述血管封堵器适配，所述血管封堵器与所述输送装置分离，从人体内退出所述输送装置，完成血管封堵器的安装。Recover the smaller or larger vascular occluder through the delivery device, change to another type of vascular occluder and continue to release and diagnose at the target position, until no smaller or larger phenomenon occurs, the current vascular occluder is considered The occluder is adapted, the blood vessel occluder is separated from the delivery device, and the delivery device is withdrawn from the human body to complete the installation of the blood vessel occluder.

本发明的积极进步效果在于：本发明的血管封堵器，具有如下有益效果：The positive progressive effect of the present invention is: the blood vessel occluder of the present invention has the following beneficial effects:

1、通过外层编织结构与封堵结构相互结合，使得该血管封堵器具有更好的效果，外层编织结构具有一定的血管堵塞的效果，再加上内部的封堵结构完全填充外层编织结构的内腔，使本血管封堵器在释放状态下形成一个类实体的封堵物，更加利于血栓的形成提高栓塞效率，实现血管栓塞的目的。1. Through the combination of the outer braided structure and the occluded structure, the vascular occluder has a better effect. The outer braided structure has a certain effect of vascular occlusion, and the inner occluded structure completely fills the outer layer The inner cavity of the braided structure enables the vascular occluder to form a solid-like occluder in the released state, which is more conducive to the formation of thrombus, improves the embolization efficiency, and realizes the purpose of vascular embolism.

并且由于封堵结构包括多跟非金属的柔性长条，在减少金属用量的基础上，能够显著提高栓塞效率。And because the plugging structure includes multiple non-metallic flexible strips, the embolization efficiency can be significantly improved on the basis of reducing the amount of metal used.

2、外层编织结构与封堵结构的近端和远端均通过固定套固定，固定牢固可靠，可避免封堵结构的部分柔性长条从外层编织结构的网眼中脱落现象。2. The proximal end and the distal end of the outer braided structure and the sealing structure are fixed by fixing sleeves, which are firm and reliable, and can prevent part of the flexible strips of the sealing structure from falling off from the mesh of the outer braided structure.

3、通过外层编织结构包裹封堵结构的设计，使得该血管封堵器不需要使用数个该装置就可实现栓塞的目的，外层编织结构的编织丝具有记忆功能，其自身的膨胀力使其血管封堵器能够紧密的与血管内部贴合，提高了栓塞的稳定性。3. Through the design of the outer braided structure wrapping the occlusion structure, the vascular occluder can achieve the purpose of embolization without using several devices. The braided wire of the outer braided structure has a memory function, and its own expansion force The blood vessel occluder can be closely fitted to the inside of the blood vessel, and the stability of embolization is improved.

4、封堵结构的柔性长条选材，特别是聚四氟乙烯的选材，具有较低的粘附性，多根柔性长条充满于外层编织结构的内腔中后，可大大减少柔性长条之前的粘附或粘连。4. The material selection of the flexible strips of the plugging structure, especially the selection of polytetrafluoroethylene, has low adhesion. After multiple flexible strips are filled in the inner cavity of the outer braided structure, the flexible strips can be greatly reduced. Adhesion or adhesion between strips.

5、外层编织结构使用的金属丝直径在0.02mm～0.15mm，使得该血管封堵器压缩后的直径达0.5mm～0.9mm，钢套的外径为0.9mm～1.4mm，使得该血管封堵器可以通过小直径导管输送，可以较为轻松的装载进5F导管中。5. The diameter of the metal wire used in the outer braided structure is 0.02mm-0.15mm, making the diameter of the vascular occluder after compression reach 0.5mm-0.9mm, and the outer diameter of the steel sleeve is 0.9mm-1.4mm, making the blood vessel The occluder can be delivered through a small-diameter catheter and can be easily loaded into a 5F catheter.

6、外层编织结构中，近端的中空圆柱形盘起到锚定减缓血流速度的作用，远端的中空圆锥形盘起诊断作用，外层编织结构的特定的形状结构设计能增加锚定能力，增加阻碍血流封堵能力，降低血管的受损概率。6. In the outer braided structure, the hollow cylindrical disk at the proximal end acts as an anchor to slow down the blood flow velocity, and the hollow conical disk at the distal end plays a diagnostic role. The specific shape and structure design of the outer braided structure can increase the anchorage. Stabilizing ability, increasing the ability to block blood flow and reducing the probability of blood vessel damage.

附图说明Description of drawings

图1为本发明实施例一提供的血管封堵器的一种结构示意图；FIG. 1 is a schematic structural view of a blood vessel occluder provided in Embodiment 1 of the present invention;

图2(a)至图2(j)为发明实施例一提供的血管封堵器的一种制作过程示意图，其中：Figure 2(a) to Figure 2(j) are schematic diagrams of a manufacturing process of the blood vessel occluder provided in Embodiment 1 of the invention, wherein:

图2(a)为实施例一提供的两端保留较长收束段的外层编织结构的一种示意图；Fig. 2 (a) is a kind of schematic diagram of the outer layer braided structure that the two ends that retain longer converging section provided by embodiment one;

图2(b)为实施例一提供的封堵结构穿过外层编织结构的中心通道后的一种示意图；Fig. 2 (b) is a kind of schematic diagram after the plugging structure provided by embodiment one passes through the central channel of the outer braided structure;

图2(c)为实施例一提供的用近端收束件捆扎收束血管封堵器近端后的一种示意图；Fig. 2 (c) is a kind of schematic diagram after the proximal end of the constricting blood vessel occluder is bundled with the proximal constricting member provided by the first embodiment;

图2(d)为实施例一提供的固定套套设于近端收束件外时的一种示意图；Fig. 2 (d) is a schematic diagram when the fixing sleeve provided by the first embodiment is sleeved outside the proximal constricting member;

图2(e)为实施例一提供的固定套套设于近端收束件外后去除多余外层编织结构和封堵结构后的一种示意图；Fig. 2 (e) is a schematic diagram of the fixed sheath provided by the first embodiment after being sleeved outside the proximal constricting member and removing the excess outer braided structure and the blocking structure;

图2(f)为实施例一提供的近端钢套压合固定套后的一种示意图；Fig. 2 (f) is a kind of schematic diagram after the near-end steel sheath that embodiment one provides is pressed and fixed sheath;

图2(g)为实施例一提供的封堵结构经发散处理完成后的一种示意图；Fig. 2 (g) is a schematic diagram of the plugging structure provided by Embodiment 1 after the divergence treatment is completed;

图2(h)为实施例一提供的用远端收束件捆扎收束血管封堵器远端后的一种示意图；Figure 2(h) is a schematic diagram of the distal end of the constricting blood vessel occluder provided by the first embodiment after the distal end constricting member is bundled;

图2(i)为实施例一提供的固定套套设于远端收束件外时的一种示意图；Fig. 2 (i) is a schematic diagram when the fixing sleeve provided by the first embodiment is sleeved outside the distal constricting member;

图2(j)为实施例一提供的固定套套设于远端收束件外后去除多余外层编织结构和封堵结构后的一种示意图；Fig. 2(j) is a schematic diagram of the fixing sleeve provided by the first embodiment after being sleeved outside the distal constricting member and removing the redundant outer braided structure and the blocking structure;

图3(a)为实施例一提供的将血管封堵器输送至血管目标位置时的一种示意图；Fig. 3 (a) is a schematic diagram of delivering the blood vessel occluder to the blood vessel target position provided by the first embodiment;

图3(b)为实施例一提供的退出输送装置后血管封堵器在血管目标位置时的一种示意图；Figure 3(b) is a schematic diagram of the blood vessel occluder at the target position of the blood vessel after withdrawing from the delivery device provided in the first embodiment;

图4为本发明实施例二提供的血管封堵器的一种结构示意图。Fig. 4 is a schematic structural diagram of a blood vessel occluder provided in Embodiment 2 of the present invention.

具体实施方式Detailed ways

为了使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解，下面结合具体图示进一步阐述本发明。In order to make the technical means, creative features, goals and effects achieved by the present invention easy to understand, the present invention will be further described below in conjunction with specific diagrams.

在本发明中，当描述血管封堵器时，“远端”、“近端”、“远段”、“近段”作为方位词，该方位词为介入医疗器械领域惯用术语，其中“远端”、“远段”表示手术过程中远离操作者的一端或一段，“近端”、“近段”表示手术过程中靠近操作者的一端或一段。In the present invention, when describing the vascular occluder, "distal end", "proximal end", "distal section" and "proximal section" are used as orientation words, which are commonly used terms in the field of interventional medical devices, wherein "far end" "end" and "distal section" mean the end or section away from the operator during the operation, and "near end" and "near section" mean the end or section close to the operator during the operation.

实施例一Embodiment one

本实施例提供一种血管封堵器6，参照图1，该血管封堵器6包括外层编织结构1、封堵结构2和两个固定套，两个固定套可以是圆环钢套，两个固定套分别为近端的固定套31和远端的固定套32。外层编织结构1具有中空内腔16。封堵结构2具有若干长条形的非金属柔性长条21，柔性长条21是柔性材质，各柔性长条21均沿外层编织结构1的长度方向延伸。各柔性长条21以发散的方式填充于中空内腔16中，具体的，各柔性长条21轴线方向的中间部分(即封堵结构2的轴线方向的中间部分)相互缠绕且发散地填充在外层编织结构1的整个中空内腔16内。This embodiment provides a blood vessel occluder 6. Referring to FIG. 1, the blood vessel occluder 6 includes an outer braided structure 1, a occluding structure 2 and two fixing sleeves. The two fixing sleeves may be circular steel sleeves. The two fixing sleeves are respectively a proximal fixingsleeve 31 and adistal fixing sleeve 32 . The outer braided structure 1 has a hollowinner cavity 16 . The sealing structure 2 has several long non-metallicflexible strips 21 made of flexible material, and eachflexible strip 21 extends along the length direction of the outer braided structure 1 . Eachflexible strip 21 is filled in thehollow cavity 16 in a divergent manner. Specifically, the middle part of eachflexible strip 21 in the axial direction (that is, the middle part of the axial direction of the sealing structure 2) is intertwined and filled in a divergent manner. In the entire hollowinner chamber 16 of the braided layer structure 1 .

外层编织结构1的第一端和封堵结构2的第一端通过固定套31固定，外层编织结构1的第二端和封堵结构2的第二端通过固定套32固定。The first end of the outer braided structure 1 and the first end of the sealing structure 2 are fixed by a fixingsleeve 31 , and the second end of the outer braiding structure 1 and the second end of the sealing structure 2 are fixed by a fixingsleeve 32 .

在有些实施例中，外层编织结构1的第一端为外层编织结构1的近端，封堵结构2的第一端为封堵结构2的近端，外层编织结构1的第二端为外层编织结构1的远端，封堵结构2的第二端为封堵结构2的远端。当然，在有些实施例中，也可以反之，即外层编织结构1的第一端为外层编织结构1的远端，封堵结构2的第一端为封堵结构2的远端，外层编织结构1的第二端为外层编织结构1的近端，封堵结构2的第二端为封堵结构2的近端。In some embodiments, the first end of the outer braided structure 1 is the proximal end of the outer braided structure 1, the first end of the closure structure 2 is the proximal end of the closure structure 2, and the second end of the outer braided structure 1 The end is the distal end of the outer braided structure 1, and the second end of the blocking structure 2 is the distal end of the blocking structure 2. Of course, in some embodiments, it can also be reversed, that is, the first end of the outer braided structure 1 is the distal end of the outer braided structure 1, the first end of the sealing structure 2 is the distal end of the sealing structure 2, and the outer The second end of the layer braided structure 1 is the proximal end of the outer braided structure 1 , and the second end of the blocking structure 2 is the proximal end of the blocking structure 2 .

本实施例的血管封堵器具有可压缩性与自膨性，或指外层编织结构1具有可压缩性与自膨性；可压缩性指可以压缩血管封堵器使其处于压缩状态，其主要目的是，使得该血管封堵器可以更好的通过输送装置进行输送，并且可以输送并植入更细的血管位置，自膨性指该血管封堵器在进入血管，通过输送装置释放出后，具有记忆功能，可以自行膨胀，从而与血管壁可以紧密贴合，提高了栓塞的稳定性，从而达到阻止血液流动，堵塞血管的作用。The vascular occluder of this embodiment has compressibility and self-expandability, or refers to that the outer braided structure 1 has compressibility and self-expandability; compressibility means that the vascular occluder can be compressed so that it is in a compressed state, and its The main purpose is to enable the vascular occluder to be better delivered through the delivery device, and can be delivered and implanted in thinner blood vessels. Self-expandability means that the vascular occluder enters the blood vessel and is released through the delivery device. Finally, it has a memory function and can expand by itself, so that it can fit closely with the blood vessel wall, improving the stability of embolism, thereby achieving the effect of preventing blood flow and blocking blood vessels.

本实施例的封堵结构2的柔性长条21是柔软的，任意弯折的，而且柔性长条21的长度在一定区间内不会影响到产品的装载与释放，只会影响外层编织结构1的内腔填充情况，柔性长条21稍短些，柔性长条21在外层编织结构1内腔发散程度会简单些；柔性长条21稍长些，发散程度就会复杂些；根据外层编织结构1尺寸的变化，柔性长条21数量或长度也会对应变化，外层编织结构1外径越大，柔性长条21数量越多或越长。所以封堵结构2通过改变长度和数量可以对外层编织结构1进行适配，从而达到充分填充且充满于内腔中的效果。封堵结构2由于充满于外层编织结构1的内腔中，使血管封堵器在释放状态下形成一个类实体的封堵物，可以阻碍血液流动，起到早期血流阻隔和致栓的作用，更加利于血栓的形成提高栓塞效率，从而实现血管栓塞的目的。Theflexible strip 21 of the plugging structure 2 of this embodiment is soft and can be bent arbitrarily, and the length of theflexible strip 21 will not affect the loading and release of the product within a certain range, but will only affect the outer braided structure 1, if theflexible strip 21 is slightly shorter, the degree of divergence of theflexible strip 21 in the inner cavity of the outer braided structure 1 will be simpler; if theflexible strip 21 is slightly longer, the degree of divergence will be more complicated; according to the outer layer As the size of the braided structure 1 changes, the number or length of theflexible strips 21 will also change accordingly. The larger the outer diameter of the outer braided structure 1, the greater the number or length of the flexible strips 21 . Therefore, the closure structure 2 can be adapted to the outer braided structure 1 by changing the length and quantity, so as to achieve the effect of fully filling and filling the inner cavity. Because the occluding structure 2 is filled in the inner cavity of the outer braided structure 1, the vascular occluder forms a solid-like occluder in the released state, which can hinder blood flow and play the role of early blood flow blocking and thrombosis. It is more conducive to the formation of thrombus and improves the embolization efficiency, so as to achieve the purpose of vascular embolism.

本实施例中的柔性长条21由于是非金属柔性结构，因此能够更好的相互缠绕并吸附血栓，达到栓塞效果。而且由于是非金属，因此能够尽可能地减少血管封堵器的金属用量，还能够显著提高栓塞效果。Since theflexible strips 21 in this embodiment are non-metallic flexible structures, they can better intertwine and absorb thrombus to achieve embolization effect. And because it is non-metal, it can reduce the amount of metal used in the blood vessel occluder as much as possible, and can also significantly improve the embolization effect.

本实施例的外层编织结构1和若干长条形的柔性长条21的近端和远端均通过固定套进行可靠固定，因此可以避免柔性长条21过短从外层编织结构1的网眼中脱落而进入血液中。本实施例的长条形的柔性长条21两端被可靠固定后，可始终位于外层编织结构1的内腔中，堵塞血管使用。The proximal end and the distal end of the outer braided structure 1 and several elongatedflexible strips 21 of the present embodiment are all reliably fixed by fixing sleeves, so that theflexible strips 21 can be prevented from being too short from the net of the outer braided structure 1. It falls out of the eye and enters the blood. After the two ends of the elongatedflexible strip 21 of this embodiment are reliably fixed, it can always be located in the lumen of the outer braided structure 1 to block blood vessels.

参照图1和图2(a)，外层编织结构1包括近端的中空圆柱形盘11和远端的中空圆锥形盘12。近端的中空圆柱形盘11起到锚定减缓血流速度的作用。为了该血管封堵器的从导管中进行释放到人体内时更加安全，本实施例的远端采用中空圆锥形盘12，中空圆锥形盘12的远端端面为弧形面。当中空圆锥形盘12远端从导管鞘中释放出且与体外圆锥形盘形状相近时，则产品较血管偏小；当释放出被严重压缩成长条状或偏长条状时，则产品较血管偏大，可以起诊断作用。但这里需说明该远端端面，包括半球型结构、球形结构、子弹型结构或抛物线绕对称轴旋转体型等具有使该血管封堵器从导管中释放到人体内的过程中有控制自膨胀速度的倾斜端面的结构。Referring to FIG. 1 and FIG. 2( a ), the outer braided structure 1 includes a proximal hollowcylindrical disc 11 and a distal hollowconical disc 12 . The hollowcylindrical disk 11 at the proximal end acts as an anchor to slow down the blood flow velocity. In order to make the blood vessel occluder safer when released from the catheter into the human body, the distal end of this embodiment adopts a hollowconical disk 12, and the distal end surface of the hollowconical disk 12 is an arc-shaped surface. When the distal end of the hollowconical disk 12 is released from the catheter sheath and is similar in shape to the external conical disk, the product is smaller than the blood vessel; Blood vessels are too large, can play a diagnostic role. However, it needs to be explained here that the distal end surface, including hemispherical structure, spherical structure, bullet-shaped structure or parabola rotating around the axis of symmetry, has the ability to control the self-expansion speed during the process of releasing the vascular occluder from the catheter into the human body. The structure of the inclined end face.

外层编织结构1为单层或多层网状结构，优选为单层网状结构，以降低人体内的金属反应，有较好的生物相容性。The outer braided structure 1 is a single-layer or multi-layer mesh structure, preferably a single-layer mesh structure, so as to reduce the metal reaction in the human body and have better biocompatibility.

如图2(a)所示，所述外层编织结构1采用记忆金属编织成型，并在编织完成后采用热定型的方式在所述外层编织结构1内形成所述中空内腔16，所述中空内腔16的内径大于所述外层编织结构的所述第一端和所述第二端的内径。As shown in Figure 2(a), the outer braided structure 1 is formed by braiding memory metal, and after the weaving is completed, the hollowinner cavity 16 is formed in the outer braided structure 1 by means of heat setting. The inner diameter of thehollow cavity 16 is larger than the inner diameters of the first end and the second end of the outer braided structure.

外层编织结构1采用金属丝编织定型而成，金属丝采用镍钛合金、钴铬合金和铂铱合金中的一种或多种。金属丝的直径为0.02mm～0.15mm，金属丝的数量可以为12/24/36/72根，使得该血管封堵器压缩后的直径可控制在0.5mm-0.9mm，可较好的装载进5F导管中。其中，镍钛合金和铂铱合金为记忆金属。The outer braided structure 1 is braided and shaped by metal wires, and the metal wires are one or more of nickel-titanium alloy, cobalt-chromium alloy and platinum-iridium alloy. The diameter of the metal wire is 0.02mm-0.15mm, and the number of metal wires can be 12/24/36/72, so that the diameter of the compressed blood vessel occluder can be controlled at 0.5mm-0.9mm, which can be better loaded into the 5F conduit. Among them, nickel-titanium alloy and platinum-iridium alloy are memory metals.

本实施例的外层编织结构1使用金属丝编织定型，使得该血管封堵器可以通过小直径导管输送。本实施例的外层编织结构1优选由36根金属丝编织而成，两端端部都有36根金属丝的头部，在将封堵结构2装入外层编织结构1的中间通道时，需要将外层编织结构1的两端撑开，会导致头端的金属丝编织网散开，无法维持编织网状，封堵结构2存在无法置入中间通道的可能，因此在对外层编织结构1热定型的时候，需要保证外层编织结构1两端较长的编织网，即如图2(a)中所示，需要保留一定长度的近端收束段13和远端收束段14为佳。The outer braided structure 1 of this embodiment is braided and shaped by wire, so that the blood vessel occluder can be delivered through a catheter with a small diameter. The outer braided structure 1 of the present embodiment is preferably braided by 36 metal wires, and there are 36 metal wire heads at both ends. , the two ends of the outer braided structure 1 need to be stretched, which will cause the wire braided mesh at the head end to scatter, and the braided mesh cannot be maintained. There is a possibility that the plugging structure 2 cannot be placed in the middle channel, so the outer braided structure 1. When heat setting, it is necessary to ensure that the two ends of the outer braided structure 1 have a longer braided mesh, that is, as shown in FIG. better.

柔性长条21采用聚四氟乙烯、超高分子聚乙烯和其他高分子聚合物材料中的一种或多种。封堵结构的柔性长条选材，特别是聚四氟乙烯的选材，具有较低的粘附性，多根柔性长条充满于外层编织结构的内腔中后，可大大减少柔性长条之前的粘附或粘连。柔性长条21的直径为0.05mm～0.15mm，柔性长条21的根数为10～24根。Theflexible strip 21 is made of one or more of polytetrafluoroethylene, ultra-high molecular polyethylene and other polymer materials. The selection of flexible strips of the plugging structure, especially the selection of polytetrafluoroethylene, has low adhesion. After multiple flexible strips are filled in the inner cavity of the outer braided structure, it can greatly reduce the amount of time before the flexible strips. adhesion or adhesion. The diameter of theflexible strip 21 is 0.05mm-0.15mm, and the number of theflexible strip 21 is 10-24.

参照图1、图2(c)和图2(h)，外层编织结构1的近端和封堵结构2的近端重叠处采用近端收束件41收束，固定套31套设于近端收束件41外。外层编织结构1的远端和封堵结构2的远端重叠处采用远端收束件42收束，固定套32套设于远端收束件42外。近端收束件41和远端收束件42优选采用铜丝。Referring to Figure 1, Figure 2(c) and Figure 2(h), the proximal end of the outer layer braided structure 1 overlaps with the proximal end of the sealing structure 2 with a proximal constrictingmember 41, and the fixingsleeve 31 is sleeved on the The near-end constricting member 41 is outside. The overlap between the distal end of the outer braided structure 1 and the distal end of the blocking structure 2 is converged by a distal constrictingmember 42 , and the fixingsleeve 32 is sheathed outside the distal constrictingmember 42 . The proximal constrictingmember 41 and the distal constrictingmember 42 are preferably copper wires.

参照图1、图2(f)和图2(g)，血管封堵器还包括近端钢套51和远端钢套52。近端钢套51的近端设置有内螺纹，近端钢套51压合于固定套31外。远端钢套52的远端为向远端凸出的圆锥体结构，致使远端钢套52为带锥度钢套，远端钢套52压合于固定套32外。Referring to FIG. 1 , FIG. 2( f ) and FIG. 2( g ), the blood vessel occluder further includes aproximal steel sheath 51 and adistal steel sheath 52 . The proximal end of theproximal steel sleeve 51 is provided with an internal thread, and theproximal steel sleeve 51 is pressed onto the outside of the fixingsleeve 31 . The distal end of thedistal steel sleeve 52 is a conical structure protruding toward the distal end, so that thedistal steel sleeve 52 is a tapered steel sleeve, and thedistal steel sleeve 52 is pressed onto the outside of the fixedsleeve 32 .

近端钢套51可用于与输送装置进行可拆卸连接，通过两者连接后，输送装置将血管封堵器送至目标位置，在对血管封堵器完全释放后，通过两者的分离，输送装置退出体内，血管封堵器留在目标位置实现血管栓塞的目的。远端钢套52为带锥度钢套。在实际使用过程中，输送装置的装载器的头部和鞘管的尾部配合再紧密都会存在一定间隙，血管封堵器远端钢套52带有锥度能够使得产品进入鞘管的时候更加顺畅，且带锥度钢套不会尖锐，降低在输送过程中对血管造成的伤害。Theproximal steel sleeve 51 can be used for detachable connection with the delivery device. After the two are connected, the delivery device sends the blood vessel occluder to the target position. After the blood vessel occluder is completely released, the two are separated to deliver The device is withdrawn from the body, and the vascular occluder stays at the target position to achieve the purpose of vascular embolization. Thesteel sleeve 52 at the far end is a tapered steel sleeve. In actual use, there will be a certain gap no matter how closely the head of the loader of the delivery device fits with the tail of the sheath. The taperedsteel sleeve 52 at the distal end of the vascular occluder can make the product enter the sheath more smoothly. And the tapered steel sleeve will not be sharp, reducing the damage to blood vessels during delivery.

固定套31、固定套32、近端钢套51和远端钢套52均采用镍钛合金、铂铱合金和高分子材料中的一种或者多种组成；固定套31、固定套32、近端钢套51和远端钢套52的外径均为0.9mm～1.4mm。The fixedsleeve 31, the fixedsleeve 32, theproximal steel sleeve 51 and thedistal steel sleeve 52 are all made of one or more of nickel-titanium alloy, platinum-iridium alloy and polymer materials; the fixedsleeve 31, the fixedsleeve 32, the proximal The outer diameters of theend steel sleeve 51 and thedistal steel sleeve 52 are both 0.9mm˜1.4mm.

参照图3(a)和图3(b)，将输送装置与近端钢套51的内螺纹进行连接，然后通过输送装置将血管封堵器输送至目标位置，最后在经过后续操作实现血管栓塞的目的。Referring to Fig. 3(a) and Fig. 3(b), the delivery device is connected to the internal thread of theproximal steel sleeve 51, and then the vascular occluder is delivered to the target position through the delivery device, and finally the blood vessel embolization is realized after subsequent operations the goal of.

实施例二Embodiment two

本实施例提供的一种血管封堵器与实施例一的不同之处在于：The difference between the blood vessel occluder provided in this embodiment and the first embodiment is that:

参照图4，本实施例的外层编织结构1有三个盘，即外层编织结构1包括近端的中空圆柱形盘11、中间的中空圆柱形盘15和远端的中空圆锥形盘12。外层编织结构1的近端与封堵结构2的近端通过固定套31及近端钢套51进行固定。外层编织结构1的远端与封堵结构2的远端通过固定套32及远端钢套52进行固定。Referring to FIG. 4 , the outer braided structure 1 of this embodiment has three disks, that is, the outer braided structure 1 includes a proximal hollowcylindrical disk 11 , a middle hollowcylindrical disk 15 and a distal hollowconical disk 12 . The proximal end of the outer braided structure 1 and the proximal end of the sealing structure 2 are fixed through the fixingsleeve 31 and theproximal steel sleeve 51 . The distal end of the outer braided structure 1 and the distal end of the blocking structure 2 are fixed through the fixingsleeve 32 and thedistal steel sleeve 52 .

远端的中空圆锥形盘12仍起诊断判定的作用。中空圆柱形盘11和中空圆柱形盘15在血液流速大、锚定空间长的血管内相比单个的圆柱盘能提供更大的锚定能力，提供更好的封堵效果。The hollowconical disk 12 at the distal end still plays a diagnostic role. The hollowcylindrical disc 11 and the hollowcylindrical disc 15 can provide greater anchoring capacity and better occlusion effect than a single cylindrical disc in blood vessels with high blood flow rate and long anchoring space.

本实施例的封堵结构中，根据外层编织结构1的内腔大小和封堵需求，柔性长条的直径与实施例一相比，设计的更大，即图4中每根柔性长条比实施例一中图1的柔性长条更粗。In the plugging structure of this embodiment, according to the inner cavity size and plugging requirements of the outer braided structure 1, the diameter of the flexible strip is designed to be larger than that of Embodiment 1, that is, each flexible strip in Figure 4 It is thicker than the flexible strip shown in Figure 1 in Embodiment 1.

需要说明的是，本实施例除了外层编织结构的形状和柔性长条粗细与实施例一不同之外，其余结构均类似，在此不多做赘述。It should be noted that, except that the shape of the braided structure of the outer layer and the thickness of the flexible strips in this embodiment are different from those in Embodiment 1, the other structures are similar, and will not be repeated here.

实施例三Embodiment Three

本实施例提供一种血管封堵器的制作方法，该方法可制作实施例一和实施例二的血管封堵器。以实施例一的血管封堵器为例，该制作方法包括如下具体步骤：This embodiment provides a method for manufacturing a blood vessel occluder, which can manufacture the blood vessel occluders of Embodiment 1 and Embodiment 2. Taking the vascular occluder of Embodiment 1 as an example, the manufacturing method includes the following specific steps:

S1，将未发散的封堵结构2穿过外层编织结构1的中间通道。S1, pass the non-divergent blocking structure 2 through the middle channel of the outer braided structure 1 .

参照图2(a)，本步骤中，外层编织结构1包括近端的中空圆柱形盘11和远端的中空圆锥形盘12。外层编织结构1选用两端保留较长编织网结构的外层编织结构1。即外层编织结构1的近端具有预设长度的近端收束段13，外层编织结构1的远端具有预设长度的远端收束段14。则该外层编织结构1包括近端的中空圆柱形盘11、远端的中空圆锥形盘12、近端收束段13和远端收束段14。Referring to FIG. 2( a ), in this step, the outer braided structure 1 includes a proximal hollowcylindrical disk 11 and a distal hollowconical disk 12 . The outer layer braided structure 1 selects the outer layer braided structure 1 that retains a longer braided mesh structure at both ends. That is, the proximal end of the outer braided structure 1 has a proximal constrictingsegment 13 of a preset length, and the distal end of the outer braided structure 1 has a distal convergingsegment 14 of a preset length. Then the outer braided structure 1 includes a proximal hollowcylindrical disk 11 , a distal hollowconical disk 12 , a proximal convergingsection 13 and a distal convergingsection 14 .

参照图2(b)，封堵结构2穿过外层编织结构1的中间通道后，至少预设长度的封堵结构2位于近端收束段13内，优选封堵结构2与近端收束段13的近端具有预设距离。Referring to Fig. 2 (b), after the blocking structure 2 passes through the middle channel of the outer braided structure 1, at least a preset length of the blocking structure 2 is located in the proximal convergingsection 13, preferably the blocking structure 2 is in contact with the proximal convergingsection 13. The proximal end of thebeam segment 13 has a preset distance.

上述设计的血管封堵器在封堵结构2的近端与近端收束段13的近端之间具有一段只有外层编织结构1的一端近端收束段，给以约束编织丝外径一个梯度，方便后续固定套31的装入。The vascular occluder of the above design has a section between the proximal end of the occluding structure 2 and the proximal end of the proximal convergingsection 13, which only has one end proximal converging section of the outer braided structure 1, and the outer diameter of the constrained braided wire A gradient facilitates the subsequent installation of the fixingsleeve 31 .

本步骤中，可通过对一根柔性长条21在中间通道对折或来回折叠的方式实现封堵结构2穿过外层编织结构1的中间通道。未发散的封堵结构2可以通过对一根柔性长条在外层编织结构1的中间通道对折或来回折叠的方式生成需要的柔性长条根数，在穿好后，将达到需要根数的柔性长条两端剪断，即可实现一根柔性长条变成多根柔性长条21的目的。In this step, the blocking structure 2 can pass through the middle passage of the outer braided structure 1 by folding aflexible strip 21 in half or back and forth in the middle passage. The non-divergent blocking structure 2 can generate the required number of flexible strips by folding a flexible strip in half or back and forth in the middle channel of the outer braided structure 1. After wearing it, it will reach the required number of flexible strips. Cutting off both ends of the strip can realize the purpose of turning one flexible strip into multipleflexible strips 21 .

多根短柔性长条在置入中间通道的过程时会存在柔性长条穿出外层编织结构的可能，而一根长柔性长条会大大降低这种风险。未发散封堵结构2可以先完全穿过外层编织结构1的中间通道，然后再从远端回拉未发散封堵结构2达到图2(b)所示效果。在图2(b)中，实现了一根柔性长条来回折叠多层形成了七根柔性长条21的效果，且封堵结构2预留了一段位于外层编织结构1的近端收束段13内形成与外层编织结构1的近端重叠段，用于后续的固定。When multiple short flexible strips are placed in the middle channel, there is a possibility that the flexible strips will pass through the outer braided structure, and one long flexible strip will greatly reduce this risk. The non-divergent blocking structure 2 can completely pass through the middle channel of the outer braided structure 1 first, and then pull back the non-divergent blocking structure 2 from the distal end to achieve the effect shown in FIG. 2( b ). In Fig. 2(b), the effect of a flexible strip being folded back and forth in multiple layers to form sevenflexible strips 21 is realized, and the closure structure 2 reserves a section located at the proximal end of the outer braided structure 1. Thesection 13 forms a section overlapping with the proximal end of the outer braided structure 1 for subsequent fixation.

S2，利用固定套31对外层编织结构1的近端和封堵结构2的近端进行固定。S2, using the fixingsleeve 31 to fix the proximal end of the outer braided structure 1 and the proximal end of the blocking structure 2 .

参照图2(c)，在利用固定套31进行固定之前，在近端收束段13内重叠的外层编织结构1和封堵结构2采用近端收束件41进行捆扎收束，捆扎收束至近端收束段13的近端端部。捆扎收束是为了使得固定套31与外层编织结构1的近端和封堵结构2的近端更稳定固定。近端收束件41优选为铜丝，从外层编织结构1和未发散封堵结构2近端重叠处用铜丝进行捆扎收束，直至外层编织结构1的近端端部，其中近端端部至近端的中部只有外层编制结构1，给以约束编织丝外径一个梯度，方便固定套31的装入。Referring to Fig. 2(c), before using the fixingsleeve 31 for fixing, the outer braided structure 1 and the blocking structure 2 overlapped in the proximal constrictingsection 13 are bundled and constricted using the proximal constrictingmember 41, and the constricting Beamed to the proximal end of the proximal convergingsection 13. The purpose of bundling is to make the fixingsleeve 31 and the proximal end of the outer braided structure 1 and the proximal end of the blocking structure 2 more stably fixed. The proximal constrictingpart 41 is preferably a copper wire, and is bundled with a copper wire from the overlap of the proximal end of the outer braided structure 1 and the undivergent sealing structure 2 until the proximal end of the outer braided structure 1, wherein the proximal From the end to the middle of the proximal end, there is only the outer weaving structure 1, which gives a gradient in the outer diameter of the restraining braiding wire, which facilitates the loading of the fixingsleeve 31.

参照图2(d)，固定套31套设于近端收束件41外。固定套31套设时，尽可能的靠近近端的中空圆柱形盘11。Referring to FIG. 2( d ), the fixingsleeve 31 is sheathed outside the proximal constrictingmember 41 . When the fixedsleeve 31 is sheathed, it is as close as possible to the hollowcylindrical disk 11 at the proximal end.

固定套31的内径略大于外层编织结构1所有编织丝聚拢后的外径，即固定套31的内径略大于近端收束段13的外径。而外层编织结构1和未发散封堵结构2聚拢后的为外径与固定套31的内径非常相近，甚至聚拢不到位的状态下会大于固定套31的内径。所以外层编织结构1的近端保留较长的编织网既能防止编织丝散开，又能使固定套31装入的时候不太困难，给固定套31的装入提供一个过渡。实现在极限的尺寸下，放入极限根数的柔性长条，以达到在尽可能小的鞘管内输送且血管封堵器内部填充尽可能饱满的效果。The inner diameter of the fixingsleeve 31 is slightly larger than the outer diameter of all the braided wires of the outer braided structure 1 , that is, the inner diameter of the fixingsleeve 31 is slightly larger than the outer diameter of the proximal convergingsection 13 . However, the outer diameter of the outer braided structure 1 and the non-divergent sealing structure 2 is very similar to the inner diameter of the fixedsleeve 31 after gathering, and even larger than the inner diameter of the fixedsleeve 31 when the gathering is not in place. Therefore, the proximal end of the outer layer braided structure 1 retains a longer braided net, which can prevent the braided wire from spreading out, and make it not too difficult to install the fixingsleeve 31 , providing a transition for the loading of the fixingsleeve 31 . Under the limit size, the limit number of flexible strips can be put in, so as to achieve the effect of delivering in the smallest possible sheath and filling the inside of the blood vessel occluder as full as possible.

参照图2(e)，将固定套31近端侧的外层编织结构1和封堵结构2全部去除。既保证固定套31装入近端钢套41一段没有毛刺，不会影响产品后期与推送杆的螺纹连接，又能使封堵结构2由一根柔性长条变成多根柔性长条21，方便后面的散开处理。Referring to FIG. 2( e ), the outer braided structure 1 and the blocking structure 2 on the proximal side of the fixedsheath 31 are all removed. It not only ensures that the fixedsleeve 31 is installed into theproximal steel sleeve 41 without burrs, and does not affect the threaded connection between the product and the push rod in the later stage, but also enables the sealing structure 2 to change from one flexible strip to multipleflexible strips 21, It is convenient to spread out later.

参照图2(f)，在利用固定套31进行固定之后，还将固定套31置入近端钢套51内进行压合固定。Referring to FIG. 2( f ), after thefixation sleeve 31 is used for fixing, thefixation sleeve 31 is also put into theproximal steel sleeve 51 for press-fitting and fixing.

S3，对封堵结构2进行发散处理，使封堵结构2填充于外层编织结构1的内腔内。S3, performing divergent treatment on the plugging structure 2, so that the plugging structure 2 is filled in the lumen of the outer braided structure 1 .

另外，发明人在研发过程中发现，非金属柔性长条21如何充分地填充在外层编织结构1内是目前最难解决的问题。因为为了避免柔性长条21逃逸出外层编织结构1外，柔性长条21长度方向的两端要与外层编织结构1长度方向的两端固定住。要在保持柔性长条21两端固定的同时，还要使柔性长条21的中间部分充分发散在外层编织结构1的中空内腔16内，这非常难实现。In addition, the inventors found in the research and development process that how to fully fill the non-metallicflexible strips 21 in the outer braided structure 1 is currently the most difficult problem to solve. Because in order to prevent theflexible strip 21 from escaping from the outer braided structure 1 , the two ends of theflexible strip 21 in the length direction should be fixed to the two ends of the outer braided structure 1 in the length direction. While keeping both ends of theflexible strip 21 fixed, it is very difficult to make the middle part of theflexible strip 21 fully diverge in the hollowinner cavity 16 of the outer braided structure 1 .

为了解决上述问题，参照图2(g)，在对外层编织结构1的近端用固定套31固定后，来回拉扯外层编织结构1的远端，封堵结构2比较柔软，没有记忆功能，外层编织结构1为记忆合金，具有记忆功能，且外层编织结构1被热定型成一个内部具有中空腔体的结构，每次拉扯，封堵结构2相对外层编织结构1运动，缩于外层编织结构1内。In order to solve the above problems, referring to Fig. 2(g), after the proximal end of the outer layer braided structure 1 is fixed with a fixingsleeve 31, the far end of the outer layer braided structure 1 is pulled back and forth, and the blocking structure 2 is relatively soft and has no memory function. The outer braided structure 1 is a memory alloy with a memory function, and the outer braided structure 1 is heat-set into a structure with a hollow cavity inside. Every time it is pulled, the sealing structure 2 moves relative to the outer braided structure 1 and shrinks to Inside the outer braided structure 1.

具体步骤可如下，当封堵结构2沿轴向穿入外层编织结构1内后，如图2(e)利用一个固定套31固定住封堵结构2和外层编织结构1的近端，然后拉住外层编织结构1的远端，带动外层编织结构1的远端往远离外层编织结构1的近端方向运动，由于外层编织结构1采用记忆金属编织成型，因此弹性很大，能够轻易被拉扯开。当外层编织结构1的远端被拉扯至无法被拉扯的状态时，外层编织结构1包覆住更多的柔性长条21，此时松手，外层编织结构1的远端回弹，则各柔性长条就被收入外层编织结构内了，同时回弹产生震动力能够将各柔性长条21弹散开，则各柔性长条21就松散且互相缠绕地填充在外层编织结构1的中空内腔21内了。The specific steps can be as follows. After the blocking structure 2 penetrates into the outer layer braided structure 1 in the axial direction, as shown in FIG. Then pull the distal end of the outer braided structure 1 to drive the distal end of the outer braided structure 1 to move away from the proximal end of the outer braided structure 1. Since the outer braided structure 1 is formed by memory metal braiding, it is very elastic , can be easily pulled apart. When the distal end of the outer braided structure 1 is pulled to a state where it cannot be pulled, the outer braided structure 1 covers moreflexible strips 21 , and when you let go, the distal end of the outer braided structure 1 rebounds, Then the flexible strips are put into the outer braided structure, and at the same time, the rebound generates a vibration force that can bounce theflexible strips 21 apart, and then theflexible strips 21 are loosely and intertwinedly filled in the outer braided structure 1 In thehollow cavity 21 of.

上述过程可以多操作几次，直到各柔性长条21装载至外层编织结构1内，则各柔性长条21就都被发散地填充在外层编织结构1的中空内腔16内了。The above process can be performed several times until eachflexible strip 21 is loaded into the outer braided structure 1 , and then eachflexible strip 21 is divergently filled in thehollow cavity 16 of the outer braided structure 1 .

上述填充方式充分地利用了外层编织结构2是记忆金属编织成型所具备的弹力特性，非常巧妙地将各柔性长条21发散地填充在外层编织结构1的中空内腔21内了。The above filling method makes full use of the elastic properties of the outer layer braided structure 2 which is formed by memory metal braiding, and very skillfully fills theflexible strips 21 in thehollow cavity 21 of the outer layer braided structure 1 in a divergent manner.

当然，需要说明的是，在有些实施例中，还可以借用外部工具固定并拉扯外层编织结构1，使得各柔性长条21装载至外层编织结构1内，例如将整个血管封堵器放置到外部工具中，并对其进行拉扯和释放处理等。Of course, it should be noted that, in some embodiments, the outer braided structure 1 can also be fixed and pulled by an external tool, so that eachflexible strip 21 is loaded into the outer braided structure 1, for example, the entire vascular occluder is placed into the external tool and do pull and release handling on it, etc.

同时，更加优选的，在拉扯的过程中，还可以通过针、镊子或其他细小的工具对封堵结构2进行人为的干预拨散，以保证封堵结构2充分填充。At the same time, more preferably, during the pulling process, the blocking structure 2 can also be manually intervened and loosened by needles, tweezers or other small tools, so as to ensure that the blocking structure 2 is fully filled.

另外，血管封堵器包括N个外层编织结构1，第i节的外层编织结构1的第一端与所述第i+1节的所述外层编织结构1的第二端连接，所述N为大于等于2的自然数，所述i为大于等于1的自然数。在本实施例中，N为2，i为1。In addition, the blood vessel occluder includes N outer braided structures 1, the first end of the outer braided structure 1 of the i-th section is connected to the second end of the outer braided structure 1 of the i+1th section, The N is a natural number greater than or equal to 2, and the i is a natural number greater than or equal to 1. In this embodiment, N is 2 and i is 1.

外层编织结构1的第一端和第二端夹持各柔性长条21，这样，当来回拉扯外层编织结构1时，外层编织结构1的第一端和第二端对柔性长条21起到夹持作用，在回弹时，能够更加方便地将柔性长条21弹散开。The first end and the second end of the outer layer braided structure 1 clamp eachflexible strip 21, like this, when the outer layer braided structure 1 is pulled back and forth, the first end and the second end of the outer layer braided structure 1 are opposite to the flexible strips. 21 plays a clamping role, and when rebounding, theflexible strip 21 can be scattered more conveniently.

当然，在实际过程中，回弹时，可以直接拉住第i+1节的外层编织结构1的远端回弹。当然，也可以分别拉住第i节和第i+1外层编织结构1的远端回弹。Of course, in the actual process, when rebounding, the distal end of the outer braided structure 1 of section i+1 can be directly pulled to rebound. Of course, it is also possible to pull the rebound at the distal ends of the i-th section and the i+1-th outer braided structure 1 respectively.

在对封堵结构2进行发散处理后，可将封堵结构2远端剪掉部分，保证封堵结构2完全在外层编织结构1的远端收束段14内，优选封堵结构2的远端距离远端收束段14的远端存在一定距离。使得封堵结构2预留了一段位于远端收束段14内形成与外层编织结构1的远端重叠段，用于后续的固定。After the divergent treatment is carried out on the plugging structure 2, the distal end of the plugging structure 2 can be cut off to ensure that the plugging structure 2 is completely in the distal convergingsection 14 of the outer braided structure 1, preferably the distal end of the plugging structure 2. There is a certain distance between the distal end and the distal end of the distal convergingsection 14. The blocking structure 2 reserves a section located in the distal convergingsection 14 to form a distal overlapping section with the outer braided structure 1 for subsequent fixation.

S4，利用固定套32对外层编织结构1的远端和封堵结构2的远端进行固定。S4, using the fixingsleeve 32 to fix the distal end of the outer braided structure 1 and the distal end of the blocking structure 2 .

参照图2(h)，利用固定套32进行固定之前，在远端收束段14内重叠的外层编织结构1和封堵结构2采用远端收束件42进行捆扎收束，捆扎收束至远端收束段14的远端端部。远端收束件42优选为铜丝，从外层编织结构1和未发散封堵结构2远端重叠处用铜丝进行捆扎收束，直至外层编织结构1的远端端部，其中远端端部至远端的中部只有外层编制结构1，给以约束编织丝外径一个梯度，方便固定套32的装入。Referring to Fig. 2(h), before fixing with the fixingsleeve 32, the outer layer braided structure 1 and the blocking structure 2 overlapped in the distal convergingsection 14 are bundled and constricted using the distal constrictingmember 42, and the constricting to the distal end of the distal convergingsection 14 . The distal constrictingmember 42 is preferably a copper wire, and is bundled with copper wire from the overlap of the distal end of the outer braided structure 1 and the non-divergent sealing structure 2 until the distal end of the outer braided structure 1, wherein the far end From the end to the middle of the distal end, there is only the outer braided structure 1, which gives a gradient in the outer diameter of the constrained braided wire to facilitate the loading of the fixingsleeve 32.

参照图2(i)，固定套32套设于远端收束件42外。固定套32套设时，尽可能的靠近远端的中空圆锥形盘12。Referring to FIG. 2( i ), the fixingsleeve 32 is sheathed on the outside of the distal constrictingmember 42 . When the fixedsleeve 32 is sheathed, it is as close as possible to the hollowconical disc 12 at the far end.

固定套32的内径略大于外层编织结构1所有编织丝聚拢后的外径，即固定套32的内径略大于远端收束段14的外径。而外层编织结构1和未发散封堵结构2聚拢后的为外径与固定套32的内径非常相近，甚至聚拢不到位的状态下会大于固定套32的内径。所以外层编织结构1的近端保留较长的编织网既能防止编织丝散开，又能使固定套32装入的时候不太困难，给固定套32的装入提供一个过渡。The inner diameter of the fixingsleeve 32 is slightly larger than the outer diameter of all the braided wires of the outer braided structure 1 , that is, the inner diameter of the fixingsleeve 32 is slightly larger than the outer diameter of the distal convergingsection 14 . After the outer braided structure 1 and the non-divergent sealing structure 2 are gathered, the outer diameter is very similar to the inner diameter of the fixedsleeve 32, or even larger than the inner diameter of the fixedsleeve 32 when the gathering is not in place. Therefore, the proximal end of the outer layer braided structure 1 retains a longer braided net, which can prevent the braided wire from spreading out, and make it not too difficult to install the fixingsleeve 32 , providing a transition for the loading of the fixingsleeve 32 .

参照图2(j)，将固定套32远端侧的外层编织结构1和封堵结构2全部去除。既保证固定套32装入远端钢套52一段没有毛刺，又能使封堵结构2由远端折叠柔性长条变成独立的柔性长条，使得封堵结构2由一根长柔性长条彻底分解为需求数量的短的柔性长条21，每根柔性长条单独受力，相互之间的影响降到最低。Referring to FIG. 2(j), the outer braided structure 1 and the blocking structure 2 on the distal side of the fixingsleeve 32 are all removed. It not only ensures that the fixedsleeve 32 is installed into thesteel sleeve 52 at the far end without burrs, but also makes the sealing structure 2 change from a folded flexible strip at the far end to an independent flexible strip, so that the sealing structure 2 is formed by a long flexible strip Thoroughly decompose into the required number of shortflexible strips 21, each flexible strip bears force independently, and the mutual influence is minimized.

在利用固定套32进行固定之后，还将固定套32置入远端钢套52内进行压合固定。参照图1，亦可视作为固定套32装入远端钢套52后压合完成后血管封堵器示意图。After thefixation sleeve 32 is used for fixing, thefixation sleeve 32 is also put into thedistal steel sleeve 52 for press-fitting and fixing. Referring to FIG. 1 , it can also be regarded as a schematic diagram of a blood vessel occluder after the fixingsleeve 32 is loaded into thedistal steel sleeve 52 and the compression is completed.

实施例四Embodiment four

本实施例提供一种血管封堵器的安装方法，该血管封堵器的外层编织结构1的远端端面为弧形面，该安装方法包括如下具体步骤：This embodiment provides a method for installing a blood vessel occluder. The distal end face of the outer braided structure 1 of the blood vessel occluder is an arc-shaped surface. The installation method includes the following specific steps:

血管封堵器压缩并通过输送装置输送至目标位置后，血管封堵器从输送装置的导管鞘中被释放到人体内血管中时，血管封堵器的远端侧首先被释放。当血管封堵器的远端侧在释放后，对血管封堵器的大小进行诊断，当血管封堵器的远端侧与血管封堵器在人体外未被压缩前具有相同的外轮廓，则认为血管封堵器较血管偏小，当血管封堵器的远端侧被压缩成长条状或偏长条状时，则认为血管封堵器较血管偏大；将偏小或偏大的血管封堵器通过输送装置回收，换一个型号的血管封堵器继续至目标位置释放并诊断，直至未出现偏小或偏大现象时，认为当前血管封堵器适配，如图3(a)所示的血管封堵器6认为适配。血管封堵器与输送装置分离，从人体内退出输送装置，完成血管封堵器的安装。如图3(b)所示的血管封堵器6被留在了血管7内，实现血管栓塞的目的。After the blood vessel occluder is compressed and delivered to the target position through the delivery device, when the blood vessel occluder is released from the catheter sheath of the delivery device into the blood vessel in the human body, the distal side of the blood vessel occluder is released first. When the distal side of the vascular occluder is released, the size of the vascular occluder is diagnosed, when the distal side of the vascular occluder has the same outer contour as that of the vascular occluder before it is compressed outside the human body, It is considered that the vascular occluder is smaller than the blood vessel, and when the distal side of the vascular occluder is compressed into a long or elongated strip, it is considered that the vascular occluder is larger than the blood vessel; the smaller or larger The vascular occluder is recovered through the delivery device, and another type of vascular occluder is continued to be released and diagnosed at the target position. When there is no phenomenon of being too small or too large, the current vascular occluder is considered suitable, as shown in Figure 3 (a ) The blood vessel occluder 6 shown in ) is considered suitable. The blood vessel occluder is separated from the delivery device, and the delivery device is withdrawn from the human body to complete the installation of the blood vessel occluder. The blood vessel occluder 6 shown in FIG. 3( b ) is left in theblood vessel 7 to realize the purpose of blood vessel embolization.

本实施例通过外层编织结构1的远端端面为弧形面实现诊断作用，诊断血管封堵器的型号与血管的大小是否适配，如果不适配则回收，换下一个型号。如果没有本实施例的诊断功能，当血管封堵器小了时不能完全封堵，当血管封堵器太大时，血管封堵器将被拉伸太长，可能影响其他血管。而一旦血管封堵器完全释放后，再回收比较麻烦，因此在完全释放前采用该诊断功能，可以在血管封堵器被完全释放前做一个预判。In this embodiment, the distal end surface of the outer braided structure 1 is arc-shaped to realize the diagnosis function, and diagnose whether the model of the vascular occluder is compatible with the size of the blood vessel. If not, it is recycled and replaced with another model. Without the diagnostic function of this embodiment, when the vascular occluder is too small, it cannot be completely blocked, and when the vascular occluder is too large, the vascular occluder will be stretched too long, which may affect other blood vessels. Once the vascular occluder is fully released, it is troublesome to retrieve it. Therefore, using this diagnostic function before the vascular occluder is fully released can make a prediction before the vascular occluder is completely released.

本实施例的远端端面，包括半球型结构、球形结构、子弹型结构或抛物线绕对称轴旋转体型等具有使该血管封堵器从导管中释放到人体内的过程中有控制自膨胀速度的倾斜端面的结构。The distal end surface of this embodiment includes a hemispherical structure, a spherical structure, a bullet-shaped structure, or a parabola that rotates around a symmetrical axis, etc., so that the vascular occluder can control the self-expansion speed during the process of releasing it from the catheter into the human body. Structure with inclined end faces.

需要强调的是，上述各实施例之间可以相互配合使用，在一个实施例中提到的细节在另一个实施例中同样有效，只是为了避免重复，好多细节就不在各个实施例中一一重复赘述了。It should be emphasized that the above embodiments can be used in conjunction with each other, and the details mentioned in one embodiment are equally effective in another embodiment, but in order to avoid repetition, many details are not repeated in each embodiment Repeatedly.

以上显示和描述了本发明的基本原理、主要特征和本发明的优点。本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的只是说明本发明的原理，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。The basic principles, main features and advantages of the present invention have been shown and described above. Those skilled in the industry should understand that the present invention is not limited by the above-mentioned embodiments. What are described in the above-mentioned embodiments and the description only illustrate the principle of the present invention. Without departing from the spirit and scope of the present invention, the present invention will also have Variations and improvements are possible, which fall within the scope of the claimed invention. The protection scope of the present invention is defined by the appended claims and their equivalents.

Claims (10)

Translated fromChinese

1.一种血管封堵器的制作方法，其特征在于，包括如下步骤：1. a kind of manufacture method of blood vessel occluder is characterized in that, comprises the steps:S1，采用具有中空内腔的外层编织结构，将未发散的封堵结构沿所述外层编织结构的轴线方向穿于所述外层编织结构的所述中空内腔内；S1, using an outer braided structure with a hollow inner cavity, and passing a non-divergent blocking structure into the hollow inner cavity of the outer braided structure along the axial direction of the outer braided structure;所述封堵结构包括若干具有长条形的非金属柔性长条，各所述柔性长条均沿所述外层编织结构的轴线方向延伸；The sealing structure includes several long non-metallic flexible strips, and each of the flexible strips extends along the axial direction of the outer braided structure;S2，利用一个固定套对所述外层编织结构的第一端和所述封堵结构的第一端进行固定；S2, using a fixing sleeve to fix the first end of the outer braided structure and the first end of the sealing structure;S3，对所述封堵结构进行发散处理，使所述封堵结构中间部分相互缠绕且发散地充盈于所述外层编织结构的整个内腔内；S3, performing divergent processing on the blocking structure, so that the middle parts of the blocking structure are intertwined and filled in the entire lumen of the outer braided structure in a divergent manner;S4，利用另一个固定套对所述外层编织结构的第二端和所述封堵结构的第二端进行固定。S4, using another fixing sleeve to fix the second end of the outer braided structure and the second end of the blocking structure.2.如权利要求1所述的血管封堵器的制作方法，其特征在于，所述外层编织结构采用记忆金属丝编织而成，所述外层编织结构采用记忆金属编织成型，并在编织完成后采用热定型的方式在所述外层编织结构内形成所述中空内腔，所述中空内腔的内径大于所述外层编织结构的所述第一端和所述第二端的内径；2. The method for making a blood vessel occluder according to claim 1, wherein the outer braided structure is braided by memory metal wire, and the outer braided structure is formed by braiding memory metal, and the braided outer layer is formed by braiding After completion, the hollow inner cavity is formed in the outer braided structure by heat setting, and the inner diameter of the hollow inner cavity is larger than the inner diameters of the first end and the second end of the outer braided structure;步骤S3中，在对所述封堵结构进行发散处理时，来回拉扯所述外层编织结构的第二端，使得所述封堵结构相互缠绕且发散地填充于所述外层编织结构的整个内腔内。In step S3, when the sealing structure is divergently processed, the second end of the outer braided structure is pulled back and forth, so that the sealing structures are intertwined and filled in the entire outer braided structure in a divergent manner Inside the lumen.3.如权利要求2所述的血管封堵器的制作方法，其特征在于，在对所述封堵结构进行发散处理时，来回拉扯所述外层编织结构的第二端，使得所述封堵结构相互缠绕且发散地填充于所述外层编织结构的整个内腔内的具体步骤如下：3. The manufacturing method of a blood vessel occluder as claimed in claim 2, characterized in that, when the occlusion structure is divergently processed, the second end of the outer braided structure is pulled back and forth, so that the occlusion The specific steps for intertwining the plugging structures and filling the entire inner cavity of the outer braided structure divergently are as follows:步骤V1：带动所述外层编织结构的远端往远离所述外层编织结构的近端方向运动，所述外层编织结构包覆住更多的各所述柔性长条，松开所述外层编织结构的远端，所述外层编织结构的远端回弹，则各所述柔性长条就被发散地收入所述外层编织结构内；Step V1: Drive the distal end of the outer braided structure to move away from the proximal end of the outer braided structure, the outer braided structure covers more of the flexible strips, and loosen the The distal end of the outer braided structure, the distal end of the outer braided structure rebounds, and each of the flexible strips is divergently received into the outer braided structure;重复上述V1步骤多次，直至各所述柔性长条相互缠绕且发散地填充于所述外层编织结构的整个内腔内；Repeat the above step V1 for several times until each of the flexible strips is intertwined with each other and divergently fills the entire inner cavity of the outer braided structure;和\或，步骤S3中，在对所述封堵结构进行发散处理时，用工具对柔性长条进行拨散。And/or, in step S3, when the sealing structure is divergently processed, the flexible long strips are loosened with a tool.4.如权利要求1所述的血管封堵器的制作方法，其特征在于，步骤S1中，所述外层编织结构的近端具有预设长度的近端收束段，所述外层编织结构的远端具有预设长度的远端收束段，所述封堵结构穿过外层编织结构的中间通道后，至少预设长度的所述封堵结构位于所述近端收束段内，优选所述封堵结构与所述近端收束段的近端具有预设距离；4. The manufacturing method of a blood vessel occluder according to claim 1, wherein in step S1, the proximal end of the outer braided structure has a proximal converging section of a preset length, and the outer braided The distal end of the structure has a distal converging section of a preset length, and after the blocking structure passes through the middle channel of the outer braided structure, at least a predetermined length of the blocking structure is located in the proximal converging section , preferably, the blocking structure has a preset distance from the proximal end of the proximal converging section;步骤S2中，利用所述固定套进行固定之前，在所述近端收束段内重叠的所述外层编织结构和所述封堵结构采用近端收束件进行捆扎收束，捆扎收束至所述近端收束段的近端端部，所述固定套套设于所述近端收束件外，并将所述固定套近端侧的所述外层编织结构和所述封堵结构全部去除；In step S2, before fixing with the fixing sleeve, the outer braided structure and the blocking structure overlapped in the proximal constricting section are bundled and constricted using a proximal constricting member, and the constricting To the proximal end of the proximal converging section, the fixing sleeve is sleeved outside the proximal constricting member, and the outer braided structure on the proximal side of the fixing sleeve and the sealing All structures are removed;和\或，步骤S1中，通过对一根柔性长条在所述中间通道对折或来回折叠的方式实现所述封堵结构穿过外层编织结构的中间通道；And/or, in step S1, realize that the blocking structure passes through the middle passage of the outer braided structure by folding a flexible strip in half or back and forth in the middle passage;和\或，步骤S2中，在利用所述固定套进行固定之后，还将所述固定套置入近端钢套内进行压合固定；And/or, in step S2, after using the fixing sleeve for fixing, the fixing sleeve is also inserted into the proximal steel sleeve for press-fitting and fixing;和\或，步骤S3中，在对所述封堵结构进行发散处理后，保证至少预设长度的所述封堵结构位于所述远端收束段内，优选所述封堵结构与所述远端收束段的远端具有预设距离；And/or, in step S3, after performing divergent processing on the blocking structure, it is ensured that at least a preset length of the blocking structure is located in the distal converging section, preferably the blocking structure is in contact with the The distal end of the distal constriction section has a preset distance;步骤S4中，利用所述固定套进行固定之前，在所述远端收束段内重叠的所述外层编织结构和所述封堵结构采用远端收束件进行捆扎收束，捆扎收束至所述远端收束段的远端端部，所述固定套套设于所述远端收束件外，并将所述固定套远端侧的所述外层编织结构和所述封堵结构全部去除；In step S4, before fixing with the fixing sleeve, the outer braided structure and the blocking structure overlapped in the distal constricting section are bundled and constricted using a distal constricting member, and the constricting To the distal end of the distal converging section, the fixing sleeve is sleeved outside the distal converging member, and the outer braided structure on the distal side of the fixing sleeve and the sealing All structures are removed;和\或，步骤S4中，在利用所述固定套进行固定之后，还将所述固定套置入远端钢套内进行压合固定。And/or, in step S4, after using the fixing sleeve for fixing, the fixing sleeve is also put into the distal steel sleeve for press-fitting and fixing.5.一种血管封堵器，其特征在于，包括：5. A blood vessel occluder, characterized in that, comprising:一外层编织结构，具有中空内腔；An outer braided structure with a hollow inner cavity;一封堵结构，若干具有长条形的柔性长条，各所述柔性长条均沿所述外层编织结构的长度方向延伸，各所述柔性长条中间部分相互缠绕且发散地充盈于所述内腔中；Blocking structure, several long flexible strips, each of the flexible strips extends along the length direction of the outer braided structure, and the middle parts of each of the flexible strips are intertwined and filled in the divergent way in the cavity;两个固定套，一个所述固定套固定于所述外层编织结构的第一端和所述封堵结构的第一端外，另一个所述固定套固定于所述外层编织结构的第二端和所述封堵结构的第二端外。Two fixing sleeves, one fixing sleeve is fixed on the first end of the outer braided structure and the first end of the sealing structure, and the other fixing sleeve is fixed on the first end of the outer braided structure two ends and the second end of the plugging structure.6.如权利要求5所述的血管封堵器，其特征在于，将封堵结构发散于所述外层编织结构过程中，可先将未发散的封堵结构沿所述外层编织结构的轴线方向穿于所述外层编织结构的所述中空内腔内；6. The blood vessel occluder according to claim 5, characterized in that, in the process of diverging the occluding structure into the outer braided structure, the non-divergent occluded structure can be firstly placed along the outer layer of the braided structure. The axial direction passes through the hollow inner cavity of the outer braided structure;来回拉扯所述外层编织结构的第二端，使得所述封堵结构相互缠绕且发散地填充于所述外层编织结构的整个内腔内。The second end of the outer braided structure is pulled back and forth, so that the blocking structures are intertwined and filled in the entire lumen of the outer braided structure in a divergent manner.7.如权利要求6所述的血管封堵器，其特征在于，所述外层编织结构采用镍钛丝编织成型，并通过热定性形成所述中空内腔，所述中空内腔的内径大于所述外层编织结构的第一端和第二端的内径；7. The blood vessel occluder according to claim 6, wherein the braided structure of the outer layer is formed by braiding nickel-titanium wire, and the hollow lumen is formed by heat setting, and the inner diameter of the hollow lumen is larger than inner diameters of the first end and the second end of the outer braided structure;所述血管封堵器包括N个所述外层编织结构，第i节的所述外层编织结构的第一端与所述第i+1节的所述外层编织结构的第二端连接，所述N为大于等于2的自然数，所述i为大于等于1的自然数。The blood vessel occluder includes N outer braided structures, the first end of the outer braided structure of the i-th section is connected to the second end of the outer braided structure of the i+1th section , the N is a natural number greater than or equal to 2, and the i is a natural number greater than or equal to 1.8.如权利要求7所述的血管封堵器，其特征在于，所述外层编织结构的第一端和第二端夹持各所述柔性长条。8. The blood vessel occluder according to claim 7, wherein the first end and the second end of the outer braided structure clamp each of the flexible strips.9.如权利要求5所述的血管封堵器，其特征在于，所述外层编织结构的近端和所述封堵结构的近端重叠处采用近端收束件收束，一个所述固定套套设于所述近端收束件外；9. The blood vessel occluder according to claim 5, wherein the proximal end of the outer braided structure overlaps with the proximal end of the occlusion structure by a proximal constricting member, and one of the The fixing sleeve is sleeved on the outside of the proximal constricting member;所述外层编织结构的远端和所述封堵结构的远端重叠处采用远端收束件收束，另一个所述固定套套设于所述远端收束件外；The distal end of the outer braided structure overlaps with the distal end of the blocking structure with a distal constricting member, and the other fixing sleeve is sleeved outside the distal constricting member;和\或，所述血管封堵器还包括：And\Or, described blood vessel occluder also comprises:一近端钢套，近端设置有内螺纹，所述近端钢套压合于近端的所述固定套外；A proximal steel sleeve, the proximal end is provided with an internal thread, and the proximal steel sleeve is pressed on the outside of the fixed sleeve at the proximal end;一远端钢套，压合于远端的所述固定套外；A distal steel sleeve, press-fitted outside the fixed sleeve at the distal end;和\或，所述外层编织结构采用金属丝编织定型而成，所述金属丝采用镍钛合金、钴铬合金和铂铱合金中的一种或多种，所述金属丝的直径为0.02mm～0.15mm；And/or, the outer braided structure is braided and shaped by metal wire, and the metal wire is one or more of nickel-titanium alloy, cobalt-chromium alloy and platinum-iridium alloy, and the diameter of the metal wire is 0.02 mm～0.15mm;和\或，所述柔性长条聚四氟乙烯、超高分子聚乙烯和其他高分子聚合物材料中的一种或多种，所述柔性长条的直径为0.05mm～0.15mm，所述柔性长条的根数为10～24根；And/or, one or more of the flexible strips of polytetrafluoroethylene, ultra-high molecular polyethylene and other polymer materials, the diameter of the flexible strips is 0.05mm to 0.15mm, the The number of flexible strips is 10 to 24;和\或，所述固定套、所述近端钢套和所述远端钢套均采用镍钛合金、铂铱合金和高分子材料中的一种或者多种组成，所述固定套、所述近端钢套和所述远端钢套的外径均为0.9mm～1.4mm；And/or, the fixed sleeve, the proximal steel sleeve and the distal steel sleeve are all made of one or more of nickel-titanium alloy, platinum-iridium alloy and polymer materials, and the fixed sleeve, the The outer diameters of the proximal steel sleeve and the distal steel sleeve are both 0.9 mm to 1.4 mm;和\或，所述外层编织结构为中空圆柱形盘或中空圆锥形盘；And/or, the outer braided structure is a hollow cylindrical disc or a hollow conical disc;和\或，所述血管封堵器包括一个或多个所述外层编织结构，位于远端的所述外层编织结构的远端端面为弧形面；And/or, the blood vessel occluder includes one or more outer braided structures, and the distal end surface of the outer braided structure at the distal end is an arcuate surface;当所述血管封堵器包括至少两个所述外层编织结构时，位于近端的所述外层编织结构为中空圆柱形盘。When the blood vessel occluder includes at least two outer braided structures, the outer braided structure located at the proximal end is a hollow cylindrical disk.10.一种权利要求5至9中任意一项所述的血管封堵器的安装方法，其特征在于，所述血管封堵器的外层编织结构的远端端面为弧形面，对所述血管封堵器的安装方法包括：10. A method for installing the blood vessel occluder according to any one of claims 5 to 9, wherein the distal end face of the outer braided structure of the blood vessel occluder is an arc-shaped surface, and the The installation methods of the vascular occluder include:将血管封堵器压缩并通过输送装置输送至目标位置后，所述血管封堵器从所述输送装置的导管鞘中被释放到人体内血管中时，所述血管封堵器的远端侧首先被释放；After the blood vessel occluder is compressed and delivered to the target position through the delivery device, when the blood vessel occluder is released from the catheter sheath of the delivery device into the blood vessel in the human body, the distal side of the blood vessel occluder first to be released;当所述血管封堵器的远端侧在释放后，对所述血管封堵器的大小进行诊断，当所述血管封堵器的远端侧与所述血管封堵器在人体外未被压缩前具有相同的外轮廓，则认为所述血管封堵器较血管偏小，当所述血管封堵器的远端侧被压缩成长条状或偏长条状时，则认为所述血管封堵器较血管偏大；When the distal side of the blood vessel occluder is released, the size of the blood vessel occluder is diagnosed, and when the distal side of the blood vessel occluder is not connected with the blood vessel occluder If it has the same outer contour before compression, it is considered that the vascular occluder is smaller than the blood vessel; The occluder is larger than the blood vessel;将偏小或偏大的所述血管封堵器通过输送装置回收，换一个型号的血管封堵器继续至目标位置释放并诊断，直至未出现偏小或偏大现象时，认为当前所述血管封堵器适配，所述血管封堵器与所述输送装置分离，从人体内退出所述输送装置，完成血管封堵器的安装。Recover the smaller or larger vascular occluder through the delivery device, change to another type of vascular occluder and continue to release and diagnose at the target position, until no smaller or larger phenomenon occurs, the current vascular occluder is considered The occluder is adapted, the blood vessel occluder is separated from the delivery device, and the delivery device is withdrawn from the human body to complete the installation of the blood vessel occluder.

Images